{"id":253066,"date":"2021-08-21T12:30:17","date_gmt":"2021-08-21T07:00:17","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=253066"},"modified":"2021-08-21T11:42:06","modified_gmt":"2021-08-21T06:12:06","slug":"uk-new-report-offers-for-strengthening-medical-devices-regulation","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2021\/08\/21\/uk-new-report-offers-for-strengthening-medical-devices-regulation\/","title":{"rendered":"UK| New report offers for strengthening medical devices regulation"},"content":{"rendered":"<p style=\"text-align: justify;\">The Regulatory Horizons Council of United Kingdom has published a new report on August 19, 2021 proposing guidelines on how UK could strengthen the regulation of medical devices, learning lessons from the response to the coronavirus (COVID-19) pandemic while boosting the UK\u2019s world-class life sciences sector.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #800000;\">Key highlights of the report are:<\/span><\/p>\n<ul>\n<li style=\"text-align: justify;\">Provides opportunities for the UK to create UK-specific regulation, post BREXIT.<\/li>\n<li style=\"text-align: justify;\">Based on the government\u2019s new Life Sciences Vision, which outlined ambitions for the sector over the next decade, putting it at the heart of plans to build back better from the pandemic<\/li>\n<li style=\"text-align: justify;\">The new proposals set out how medical devices such as pacemakers or implantable defibrillators should be regulated to ensure we can tackle healthcare challenges effectively, now and in the future.<\/li>\n<li style=\"text-align: justify;\">The report recognizes the need to build a UK-specific regulatory system that puts patients at the heart of decision-making processes &#8211; for example by increasing patient representation on expert groups for advice on medical research and devices, and by providing evaluations of medical devices that are easily understandable.<\/li>\n<li style=\"text-align: justify;\">It highlights the opportunities now available to the UK, not only to respond more quickly to new advances in technology, but to work with like-minded countries in shaping international regulation.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<hr \/>\n<p><span style=\"color: #000080;\">*Tanvi Singh, Editorial Assistant has reported this brief.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Regulatory Horizons Council of United Kingdom has published a new report on August 19, 2021 proposing guidelines on how UK could <\/p>\n","protected":false},"author":121,"featured_media":199258,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14,4],"tags":[],"class_list":["post-253066","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-foreign","category-legislationupdates"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.4 (Yoast SEO v26.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>UK| New report offers for strengthening medical devices regulation | SCC Times<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.scconline.com\/blog\/post\/2021\/08\/21\/uk-new-report-offers-for-strengthening-medical-devices-regulation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" 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Regulation (MDR) entered into effect after a four-year transitional period. The Regulation introduces various changes which will have an effect on the supply chain for medical devices. \u00a0 Mr. Murali Neelakantan says that \"MDR requires Pharma companies to display unique device identification\u2026","rel":"","context":"In &quot;Foreign Legislation&quot;","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/06\/MDR-Requirements1.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":103881,"url":"https:\/\/www.scconline.com\/blog\/post\/2017\/02\/05\/medical-devices-rules-2017-to-remove-regulatory-bottlenecks\/","url_meta":{"origin":253066,"position":1},"title":"Medical Devices Rules, 2017 to remove regulatory bottlenecks","author":"Saba","date":"February 5, 2017","format":false,"excerpt":"The Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.\u00a0 Only 15 categories of medical devices are, at present, regulated as drugs and to\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":268352,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/06\/14\/fitness-wearables-and-the-law-in-eu\/","url_meta":{"origin":253066,"position":2},"title":"Fitness Wearables and the Law in EU","author":"Bhumika Indulia","date":"June 14, 2022","format":false,"excerpt":"by Shantanu Mukherjee\u2020 and Anushka Iyer\u2020\u2020 Cite as: 2022 SCC OnLine Blog Exp 49","rel":"","context":"In &quot;Op Eds&quot;","block_context":{"text":"Op Eds","link":"https:\/\/www.scconline.com\/blog\/post\/category\/op-ed\/legal-analysis\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/06\/MicrosoftTeams-image-249.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/06\/MicrosoftTeams-image-249.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/06\/MicrosoftTeams-image-249.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/06\/MicrosoftTeams-image-249.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/06\/MicrosoftTeams-image-249.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":291373,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/05\/05\/ministry-of-chemicals-and-fertilizers-notified-national-medical-devices-policy-2023-legal-news\/","url_meta":{"origin":253066,"position":3},"title":"MoC&#038;F notifies National Medical Devices Policy, 2023","author":"Kriti","date":"May 5, 2023","format":false,"excerpt":"On 3-5-2023, the Ministry of Chemicals and Fertilizers notified the National Medical Devices Policy, 2023. Key Points: 1. Medical devices constitute a multi-disciplinary sector, with the following classification: \u25cf Electronic equipment \u25cf Implants \u25cf Consumables and Disposables \u25cf Surgical instruments \u25cf In-Vitro Diagnostic Reagents 2. Objective: : \u25cf The Policy\u2026","rel":"","context":"In &quot;Legislation Updates&quot;","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"ministry of chemicals and fertilizers","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/ministry-of-chemicals-and-fertilizers.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/ministry-of-chemicals-and-fertilizers.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/ministry-of-chemicals-and-fertilizers.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/05\/ministry-of-chemicals-and-fertilizers.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":245997,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/03\/23\/china-new-medical-device-regulations-effective-from-1st-june-2021\/","url_meta":{"origin":253066,"position":4},"title":"China | New Medical Device Regulations, effective from 1st June, 2021","author":"Prachi Bhardwaj","date":"March 23, 2021","format":false,"excerpt":"China has passed New Medical Device Regulations which shall come into force from 1st June, 2021. It regulates the supervision and administration of medical devices. The key features[1] are: \u00a0 The classification and administration of medical devices will be done by state on the basis of level of risk. The\u2026","rel":"","context":"In &quot;Foreign Legislation&quot;","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/03\/MicrosoftTeams-image-23.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/03\/MicrosoftTeams-image-23.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/03\/MicrosoftTeams-image-23.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/03\/MicrosoftTeams-image-23.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/03\/MicrosoftTeams-image-23.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":274822,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/10\/01\/fitness-wearables-and-the-law-part-iii-india\/","url_meta":{"origin":253066,"position":5},"title":"Fitness Wearables and the Law Part III: India","author":"Bhumika Indulia","date":"October 1, 2022","format":false,"excerpt":"by Shantanu Mukherjee\u2020 and Anushka Iyer\u2020\u2020 Cite as 2022 SCC OnLine Blog Exp 73","rel":"","context":"In &quot;Op Eds&quot;","block_context":{"text":"Op Eds","link":"https:\/\/www.scconline.com\/blog\/post\/category\/op-ed\/legal-analysis\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Fitness-Wearables-and-the-Law-Part-III-India-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Fitness-Wearables-and-the-Law-Part-III-India-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Fitness-Wearables-and-the-Law-Part-III-India-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Fitness-Wearables-and-the-Law-Part-III-India-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Fitness-Wearables-and-the-Law-Part-III-India-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/253066","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/users\/121"}],"replies":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/comments?post=253066"}],"version-history":[{"count":0,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/posts\/253066\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media\/199258"}],"wp:attachment":[{"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/media?parent=253066"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/categories?post=253066"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.scconline.com\/blog\/wp-json\/wp\/v2\/tags?post=253066"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}